Vladimír Uličiansky, Zbynek Schroner
The EDITION studies were randomized, open-label phase IIIa studies, with similar designs and endpoints. EDITION 1, 2 and 3 studies, compared the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with insulin glargine 100 U/ml (Gla-100) in people with type 2 diabetes. Gla-300 provides comparable glycaemic control to Gla-100 with consistently less nocturnal hypoglycaemia and less hypoglycaemia at any time of day. In long-duration type 1 diabetes (EDITION 4), Gla-300 provides similar glucose control to Gla-100, with a lower risk of hypoglycemia after transfer from other insulins, and less weight gain. In the EDITION studies no between-treatment differences in the safety profile were identified. Treatment with Gla-300 was associated with a somewhat higher dose requirement and less weight gain. Clinical implications of these results center on the lower rate of hypoglycemia, which may help to overcome a major obstacle to the initiation and maintenance of insulin therapy